1. Field of the Invention
This invention relates to the treatment sexual dysfunction, particularly sexual desire, arousal, orgasmic and premature ejaculation disorders.
2. Background
Atomoxetine HCl has been the subject of clinical studies for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has received FDA approval as the prescription drug Strattera™ (Eli Lilly and Company) for the treatment of ADHD in Nov. 2002. Atomoxetine, originally named tomoxetine, is a selective norepinephrine reuptake inhibitor. Tomoxetine was first disclosed in U.S. Pat. No. 4,314,081. Tomoxetine is also disclosed in U.S. Pat. No. 6,184,222 as a treatment for conduct disorder. The word “atomoxetine” will be used herein to refer to any acid addition salt or the free base of the molecule.
The regulation of norepinephrine and dopamine plays a crucial role in our mental and physical health.
Dopamine agonists have been administered to treat various disorders of sexual dysfunction. Apomorphine, a direct acting dopamine agonist, has demonstrated an erectogenic effect in human subjects. Several other direct acting dopamine agonists such as bromocriptine, quinelorane, lisuride and pergolide that have been discussed in the related art, have had limited efficacy in treating sexual dysfunction.
Other drugs have been introduced in an attempted to treat sexual dysfunction. They include administering amantadine, buspirone, cyproheptadine, phentolamine and yohimbine. These attempts at pharmaceutical intervention have also demonstrated limited efficacy.
Viagra™ (sildenafil: a phosphodiesterase 5 inhibitor) has been used successfully in the treatment of erectile dysfunction. Since phosphodiesterase 5 (PDE 5) inhibitors have demonstrated substantial efficacy, an abundance of research has been directed toward the treatment of erectile dysfunction by way of the PDE 5 mechanism. Consequently, product development research for the treatment of the other disorders of sexual dysfunction (i.e., sexual desire or orgasmic disorders in both men and women) has been minimal when compared to research pertaining to erectile dysfunction.
The FDA has provided guidance recommendations for clinical development of drug products for the treatment of female sexual dysfunction (FSD). FSD currently consists of four recognized components: decreased sexual desire, decreased sexual arousal, persistent difficulty in achieving or inability to achieve orgasm and dyspareunia. Commentary by numerous treatment centers and pharmaceutical companies to the FDA's guidance stressed that decreased desire is the most predominant factor that needs to be addressed regarding FSD. Research has begun to develop therapeutics to treat female vasculogenic impairment as it relates to sexual arousal disorders. However, development of effective treatments for psychogenic and other organic etiologies of FSD has been minimal.
Emotional problems and changes in sexual desire are almost always associated with each other. However, changes in sexual desire without associated emotional problems or organic abnormalities are relatively common. Therefore, sexual desire disorders appear to be a core problem with which other disorders of sexual dysfunction may overlap. Therefore, there is a continued need to develop effective pharmaceutical treatment for sexual dysfunction that manifests from a decrease or absence of sexual desire.
In view of the aforementioned deficiencies attendant with the related art, the need still exists for rapid, reliable, and convenient method for treating sexual dysfunction suitable for men and women.